The use of biocompatible materials in medical devices involves the consideration of the intended use, time of exposure and location (skin surface/topical, implant, external communication, blood circulation, etc.). The use of implants for the human body began in the late 1950s; those uses require assurance that the materials and devices are safe and effective. Implantable medical devices are expected to function for many years, stay attached to its relevant area/organ and not cause any adverse response from tissue that could compromise the performance of the device or the health of the patient. The biocompatibility of a medical device material depends on corrosion, degradation or a specific biological response. Examples of such materials include corrosion resistant alloys (titanium, cobalt, platinum), inert oxide ceramics (alumina, zirconia), and biostable polymers (polyethylene, polypropylene, polytetrafluoroethylene). Biomaterial safety requirements include minimizing interactions with human body tissue and development of bodily resistance. Biomaterials must pass biological safety tests in in vitro and in vivo studies. Coatings used may be a key factor in implantable devices. Often the use of polymer coating is used to improve surface roughness, enhance lubricity, and improve resistance to friction, chips and device impact protection, inhibition of blood coagulation, hydroscopic or hydrophobic surfaces. Biological medical devices must undergo characterization analyses of biological and toxicological risks from extractable and leachable materials, including cleaning and sterilization residues, and the potential risk to the patient must be evaluated. See ISO 10993-17:2002, Biological evaluation of medical devices – Part 17: Establishment of allowable limits for leachable substances, for details about why risk assessment is an essential part of material biocompatibility and necessary for ensuring patient health and safety.
Biochem has been advising biomedical companies for more than 13 years.
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